Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

June 22, 2015 updated by: Kyung Won Kim, Asan Medical Center
Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced) and DWI MRI can provide valuable information regarding tumor biology and response to treatment through various parameters. Validating stability of these parameters will further establish robustness and reliability of these promising biomarkers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of metastatic liver cancer proven by pathology
  • At least one liver tumor should be > 2cm in long diameter
  • Patients with viable tumor proven in the other imaging modalities

Exclusion Criteria:

  • Severe claustrophobia
  • Presence of MRI-incompatible metallic objects or implanted medical devices in body
  • Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2
  • Weight greater than that allowable by the MRI table
  • Chemotherapy within 28 days prior to enrollment
  • Prior external radiation therapy to the liver, prior transarterial chemoembolization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCE and DWI MRI
MRI SCAN 1 and MRI SCAN 2 must be completed no less than 2 calendar days (to ensure 24 hours for clearance of gadolinium) and no greater than 14 days apart, and both must be completed prior to new treatment initiation. The same MRI unit and configuration must be used for MRI SCAN 1 and MRI SCAN 2.
Other: DCE MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
repeatability coefficient (RC)
Time Frame: one year
Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Bracco Diagnostics, Inc

Investigators

  • Principal Investigator: Kyung Won Kim, M.D., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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